Category: Products & Treatment

Products & Treatment

Recall for GE Healthcare Patient Monitoring System

GE HealthCare has issued updated use instructions for Portrait Mobile Monitoring Solutions devices operating on certain versions of Portrait Core Services software, according to an FDA alert.

Products & Treatment

Brinsupri/Brensocatib Approved for Bronchiectasis in Japan

Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Brinsupri (brensocatib 25-mg tablet), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and pediatric patients 12 years and older, according to Insmed Inc.

Products & Treatment

Capnography and Pulse Oximetry in the PICU

For patients in the pediatric ICU, pulse oximetry and waveform capnography are valuable tools to monitor the effectiveness of respiratory support and to inform treatment decisions.

Industry & Regulatory News

Hamilton Medical Recalls Breathing Circuit Set

Hamilton Medical issued a recall for certain coaxial breathing circuit sets used with C1, T-1, and MR1 ventilators, ordering them removed from where they are used or sold, according to an FDA alert.

Pharmaceuticals

Study to Evaluate Effectiveness of Brensocatib for Bronchiectasis

The BEST-BE observational study will track 1,000 bronchiectasis patients to measure the impact of brensocatib on pulmonary exacerbations and patient quality of life.

Diagnostics & Testing

Co-Diagnostics Submits Co-Dx PCR Flu A/B & RSV Test for FDA Clearance

Co-Diagnostics submitted a dual 510(k) premarket notification and CLIA Waiver by Application to the FDA for its Co-Dx PCR Flu A/B & RSV multiplex respiratory test.

Monitoring & Treatment

Prototype Pulse Oximeter Targets Skin Tone Bias

The ChromaSense pulse oximeter aims to eliminate skin tone bias by using reflective light technology to provide accurate oxygen saturation readings across diverse patient populations.